What are the benefits of participating in a clinical trial for gynaecological cancer?

Posted in gynaecological cancer, clinical trials; Posted 3 years ago by Andreas Obermair

Gynaecological cancer clinical trials address the concern that for some types of treatment the evidence to support those treatments is weak. Trials aim to develop the most effective and least harmful way, which is called the best standard of care for women affected by gynaecological cancer. This could be through research on the causes of cancer, developing improved medications or surgical procedures, or preventing gynaecological cancer.

Benefits of clinical trial participation

While there is benefit to the community, there is also potential benefit for individuals who participate in clinical trials.

• Trials offer access to the newest (and potentially beneficial) treatments before they are made available to everyone as standard practice. You may be the first to benefit from new treatment that could be less invasive, more effective and have less side effects than currently available treatments.
• Advice and support from the researchers who are experts in their respective fields which can lead to greater understanding and knowledge of your cancer.
• It allows you to have a more proactive role in your health care. Some participants say this makes them feel like they are more in control of their healthcare situation.
• Close monitoring of your condition by specialised doctors, and you may receive more frequent surveillance and health checks.
• There should be no costs involved to participate in a clinical trial. Clinical trials may pay for your treatment received as part of the study.

Clinical trials may be most valuable to patients with rare cancers where there is limited research evidence currently available on how to best manage and treat the disease.

It is also a good feeling knowing you may be helping others receive better treatments in the future. The current standard practice you receive today, such as any surgical procedure or medication, is due to others participating in clinical trials.

It is also worth noting that researchers spend a lot of time designing clinical trials in such ways that whatever diagnostic or treatment intervention the patients receives, patients (virtually never) are disadvantaged. However, with any intervention, there are also potential risks with trialed treatments.   

Risks of clinical trial participation

There may also be risks, such as:

• Potential side effects of treatment. New drugs or procedures are tested in clinical trial first because we do not know exactly how they may affect the patient.
• The new treatment may not be successful, or may not be better than standard treatment. It may work in some participants, but not in others.
• You may be in the control or placebo group (which means you do not receive the new treatment). Some clinical trials may have multiple treatment groups, and you cannot choose which treatment you receive.
• Clinical trial may require more of your time. Due to the surveillance required you may be asked to undergo more testing or doctors’ visits than you usually would for standard treatment.

Clinical trials in Australia are approved by ethics committees which provide careful review that study participants are not exposed to any unnecessary risks. All clinical trials follow a clinical trial protocol, which explains how the trial will run.

Informed consent

The procedures including benefits and risks of a clinical trial are described in the participant information and consent form as part of the process of informed consent. Before joining a clinical trial, you will be told what to expect and asked to provide informed consent.  You can withdraw from a clinical trial at any time, for any reason (or not provide a reason at all). There are no requirements to participate in clinical research, and the decision is entirely up to you. Whether you are suitable for a clinical trial should be discussed with your treating doctor. Before participating in a clinical trial you should ask:

• What is the aim of the clinical trial?
• Has this intervention been tested before?
• Who is funding the research?
• Who has reviewed and approved it?
• What will my participation involve (such as medical tests, medications, surgery, lifestyle modifications)?
• What are the benefits and risks?
• How long will the clinical trial run for?
• Who will pay for the health care I receive in this trial?
• Who will be in charge of my health care?
• What will happen after the trial has ended?

Current gynaecological cancer clinical trials

An example of a current clinical trial that I am involved in at the Queensland Centre for Gynaecological Cancer (QCGC) Research is the ECHO-R study. Exercise has been suggested as a way to reduce physical and psychological side effects of chemotherapy during ovarian cancer treatment. ECHO-R aims to evaluate the benefits of an individually tailored, exercise program during chemotherapy for recurrent ovarian, primary peritoneal or fallopian tube cancer.

All women who will join this study will participate in an individually tailored, home-based, 6-month exercise program throughout their chemotherapy treatment.  Overall, we hope the exercise program delivered in ECHO-R will improve physical wellbeing, quality of life, ability to tolerate treatment and ultimately survival.

If you would like further information about the study or participating, please contact me.

Other clinical trials currently underway for gynaecological cancer research are listed at the QCGC Research website.